search
Back to results

Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness

Primary Purpose

Sudden Deafness

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate ganglion block
Facial and glossopharyngeal nerve blocks
Mecobalamin Tablets
Sponsored by
Zhuan Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Deafness focused on measuring Sudden deafness, Stellate Ganglion Block, Facial nerve block, Glossopharyngeal nerve block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet the diagnostic criteria for sudden deafness established by the Editorial Board of the Chinese Journal of Otolaryngology, Head and Neck Surgery and the Chinese Society of Otolaryngology, Head and Neck Surgery Age 18 to 80 years ASA classification Ⅰ~Ⅲ grade Exclusion Criteria: Acoustic conductance test, vestibular function test, cranial MRI, etc. suggest organic disease People with coagulation disorders or on anticoagulation therapy Infection at the puncture site Severe systemic diseases that cannot cooperate with treatment

Sites / Locations

  • the Affiliated Hospital of Yangzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Stellate ganglion block combined with facial and glossopharyngeal nerve block group

Stellate ganglion block group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Mean Hearing Threshold (PTA)
The average of hearing thresholds at six frequencies (250, 500, 1000, 2000, 4000, and 8000 Hz) was recorded as the mean hearing threshold (PTA).

Secondary Outcome Measures

Full Information

First Posted
November 13, 2022
Last Updated
November 18, 2022
Sponsor
Zhuan Zhang
search

1. Study Identification

Unique Protocol Identification Number
NCT05623384
Brief Title
Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness
Official Title
Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhuan Zhang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Sudden deafness is a sudden, unexplained sensorineural hearing loss of ≥20 dBHL in at least two adjacent frequencies within 72 h. It may be accompanied by tinnitus, a sense of ear congestion, vertigo and other Symptoms.Stellate ganglion block increases the blood flow and blood velocity in the inner ear, keeping the body's vegetative, endocrine and immune functions normal.The branches of the facial and linguopharyngeal nerves are connected to the inner ear, and local injection can nourish the nerves and improve local circulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Deafness
Keywords
Sudden deafness, Stellate Ganglion Block, Facial nerve block, Glossopharyngeal nerve block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stellate ganglion block combined with facial and glossopharyngeal nerve block group
Arm Type
Experimental
Arm Title
Stellate ganglion block group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Stellate ganglion block
Intervention Description
A cross-sectional scan with a high-frequency line array probe reveals the pre-C6 transverse nodule or C7 transverse process, and the structures of the thyroid, carotid sheath, vertebral artery, inferior thyroid artery, trachea, and esophagus are identified by observation. The carotid sheath is pushed out as far as possible laterally, the needle is inserted in the paratracheal sulcus, and the tip of the needle is passed through the lateral border of the thyroid into the deep anterior fascial surface of the long cervical muscle.After backdrawing no blood, cerebrospinal fluid or gas, 5 ml of lidocaine was injected.(lidocaine 80mg;Physiological saline 1ml)
Intervention Type
Procedure
Intervention Name(s)
Facial and glossopharyngeal nerve blocks
Intervention Description
The operator touches the position of the mastoid process and needles vertically at the front of the mastoid process directly below the external auditory canal. When the surface of the mastoid is touched, the needle is adjusted to pass through the front of the mastoid and then slowly needled for about 1 cm, and when the patient develops swelling and pain, 3 ml of the drug is injected. then the needle is slowly needled backward for about 1 cm, and when the patient develops swelling and pain, 2 ml of the drug is injected. (mecobalamin injection 1mg;lidocaine 20mg; dexamethasone 10mg ;Physiological saline 2ml)
Intervention Type
Drug
Intervention Name(s)
Mecobalamin Tablets
Intervention Description
oral Mecobalamin Tablets tid-8
Primary Outcome Measure Information:
Title
Mean Hearing Threshold (PTA)
Description
The average of hearing thresholds at six frequencies (250, 500, 1000, 2000, 4000, and 8000 Hz) was recorded as the mean hearing threshold (PTA).
Time Frame
Baseline (Before treatment),1 month and 2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the diagnostic criteria for sudden deafness established by the Editorial Board of the Chinese Journal of Otolaryngology, Head and Neck Surgery and the Chinese Society of Otolaryngology, Head and Neck Surgery Age 18 to 80 years ASA classification Ⅰ~Ⅲ grade Exclusion Criteria: Acoustic conductance test, vestibular function test, cranial MRI, etc. suggest organic disease People with coagulation disorders or on anticoagulation therapy Infection at the puncture site Severe systemic diseases that cannot cooperate with treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhuan zhang, professor
Phone
+8615062791355
Email
zhangzhuancg@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhuan zhang, professor
Organizational Affiliation
The Affiliated Hospital of Yangzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhuan zhang, professor
Phone
+8615062791355
Ext
+8615062791355
Email
zhangzhuancg@163.com

12. IPD Sharing Statement

Learn more about this trial

Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness

We'll reach out to this number within 24 hrs